University of Wisconsin KnowledgeBase

As
part of its commitment to the protection of the rights and welfare of
individuals participating in research and compliance with federal regulations
governing human subjects research, research activities involving
self-experimentation require review by a University of Wisconsin-Madison
Institutional Review Board (IRB).The
Common Rule and Food and Drug Administration (FDA) do not regard research on
oneself as different from research involving other human subjects.Prior to commencing any research activities
involving self-experimentation (e.g., blood draws, equipment testing), an
Initial Review Application must be submitted to and approved by an appropriate
UW-Madison IRB.The IRB will review the
application to ensure the activities do not raise any ethical concerns and that
adequate protections are in place.

The
Common Rule and FDA regulations also require that informed consent be obtained
from all research participants unless certain conditions are met.The IRB recommends researchers provide with
their Initial Review Application a document based on the template below that
will serve as the basis for documentation of informed consent for participation
in human subjects research when the experimentation involves the researcher.